UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The utility of home blood pressure for the early detection of pregnancy-induced hypertension.(Multicenter prospective study)
Title of the study (Brief title)	The utility of home blood pressure for the early detection of pregnancy-induced hypertension.(Multicenter prospective study)
Region	Japan

Condition
Condition	Pregnancy induced Hypertension
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	For the purpose of early detection of pregnancy hypertension syndrome, we will investigate the usefulness of home blood pressure measurement, establish the normal value, and the timing of treatment intervention to clarify the relationship between gestational week number and blood pressure value.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The distribution and transition of home blood pressure values of normal pregnancy and patient of PIH by every number of gestational weeks.
Key secondary outcomes	The relationship between home and clinic blood pressure in normal and patient of PIH on every number of gestational weeks.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	45 years-old >=
Gender	Female
Key inclusion criteria	The pregnant women who visit our hospital and got its consent
Key exclusion criteria	the pregnant women who have complications of hypertension, diabetes, gestational diabetes mellitus, thyroidal dysfunction, renal function disorder, or mental disease and the women with placental previa
Target sample size	30

Research contact person
Name of lead principal investigator	Atsuo Itakura
Organization	Juntendo University
Division name	Department of Obstetrics and Gynecology
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan
TEL	03-3813-3111
Email	hirai-c@juntendo.ac.jp

Public contact
Name of contact person	Chihiro Hirai
Organization	Juntendo University
Division name	Department of Obstetrics and Gynecology
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan
TEL	03-3813-3111
Homepage URL
Email	hirai-c@juntendo.ac.jp

Sponsor
Institute	Department of Obstetrics and Gynecology, Faculty of Medicine, Aichi Medical University School of Medicine
Institute
Department

Funding Source
Organization	Japan Society for the Study of Hypertension in Pregnancy
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 02 Month 19 Day
Anticipated trial start date	2016 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Among the data collection of the pregnant woman who obtained its consent, it is non-analysis

Management information
Registered date	2018 Year 03 Month 29 Day
Last modified on	2018 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035905